Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of PRP in Endometrial Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249415
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Fundación IVI

Brief Summary:
Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes; some causes result from issues related to the endometrium. Unfortunately, no cure exists for medical conditions resulting in the destruction of the endometrium, or for non-functional uterus. Thus, safe and effective therapies are needed to treat these diseases and to establish fertility in affected women. These novel techniques refer to the use and application of regenerative/paracrine factors to regenerate the endometrium in patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP) from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution and/or effect in the endometrial repair by functional proofs.

Condition or disease
Asherman Syndrome Endometrial Atrophy

Detailed Description:
The objective is to know the effect of these regenerative factors obtained from Platelet-Rich Plasma in an immunodeficient murine model with AS/EA Blood from patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA) will be collected, maintained under anticoagulant solution and after several centrifugations PRP will be obtained. Demonstration of a functional endometrium will be proved determining pregnancy and implantation rates as well as the number of live pups/pregnant female in our mice model. Also, the uterus histology will be analysed in treated and untreated mice

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Endometrial thickness after reconstruction in murine model [ Time Frame: through study completion, an average of 1 year ]
    Using histological and functional technologies demonstration of regeneration ability of PRP


Biospecimen Retention:   Samples Without DNA
Platelet-Rich Plasma from Whole Blood.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant with endometrial pathologies.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
Criteria

Inclusion Criteria:

  • Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
  • No pregnancy after hormonal treatment.

Exclusion Criteria:

  • Psychiatric diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249415


Contacts
Layout table for location contacts
Contact: Irene Cervello, PhD 0034963903305 Irene.Cervello@ivi.es

Locations
Layout table for location information
Spain
IVI Barcelona Recruiting
Barcelona, Spain
Contact: Irene Cervelló         
Sponsors and Collaborators
Fundación IVI
Investigators
Layout table for investigator information
Principal Investigator: Irene Cervello, PhD Fundación IVI
Publications of Results:
Layout table for additonal information
Responsible Party: Fundación IVI
ClinicalTrials.gov Identifier: NCT03249415    
Other Study ID Numbers: 1701-FIVI-003-IC
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: May 2020
Keywords provided by Fundación IVI:
Platelet-Rich Plasma
Cell therapy
Regenerative factors
Autologous treatment
Paracrine factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Gynatresia
Atrophy
Pathological Conditions, Anatomical